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Recruiting Observational

Ultrasound Image Bank: Advancing Medical Research and Diagnostics

NCT07031921 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2025-06-25
Last updated
2026-03-12

Condition(s) studied

Gynecological ImagingUltrasound DiagnosticsGynecologic Disease

Study summary

The study titled "Ultrasound Image Bank: Advancing Medical Research and Diagnostics", sponsored by the Fondazione Policlinico Universitario A. Gemelli IRCCS, aims to create a large-scale database of gynecological ultrasound images. These images will be collected during routine clinical care from both healthy patients and those with benign or malignant gynecological conditions. The goal is to support medical training, clinical research, and the development of artificial intelligence (AI) models for diagnostic purposes.

This is a prospective, observational, single-center study, with an expected enrollment of approximately 25,000 patients over five years. The ultrasound images will be linked to histological outcomes (for those undergoing surgery within 3 months) or to follow-up scans at 1 year, to enhance early diagnosis and personalized treatment approaches.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * All patients examined at Class Ultrasound OMIC of Fondazione Policlinico Gemelli, IRCCS in Rome. * All patients can be enrolled regardless the results of ultrasound examination: no evidence of disease, suspicion of benign or malignant pathologies * Aged ≥ 18 years old * Patients who were previously enrolled and their outcome has been completed * Signature of informed consent Exclusion Criteria: * No signed informed consent;

Primary outcome measure(s)

  • Establishment of a digital ultrasound image biobank including follow-up data — Up to 12 months after initial ultrasound examination (including follow-up data)
    Systematic prospective collection and storage of 2D ultrasound images and video clips from patients undergoing gynecological ultrasound examinations. Each record will be associated with follow-up data, including histological results (within 3 months post-surgery, if applicable) and/or ultrasound re-evaluation (at 1-year follow-up). The goal is to generate a comprehensive image biobank for future research, including artificial intelligence studies.

Trial sites (1)

FacilityCityRegionStatus
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Roma Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07031921 on ClinicalTrials.gov ↗ ← All trials in Italy